CN105377361B - The multi-electrode conducting wire with backing for machinery/pressoreceptor stimulation - Google Patents
The multi-electrode conducting wire with backing for machinery/pressoreceptor stimulation Download PDFInfo
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- CN105377361B CN105377361B CN201480039854.9A CN201480039854A CN105377361B CN 105377361 B CN105377361 B CN 105377361B CN 201480039854 A CN201480039854 A CN 201480039854A CN 105377361 B CN105377361 B CN 105377361B
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- neural stimulation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0551—Spinal or peripheral nerve electrodes
- A61N1/0553—Paddle shaped electrodes, e.g. for laminotomy
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
- A61N1/36114—Cardiac control, e.g. by vagal stimulation
- A61N1/36117—Cardiac control, e.g. by vagal stimulation for treating hypertension
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- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Radiology & Medical Imaging (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
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- Electrotherapy Devices (AREA)
Abstract
A kind of electrode structure of implantable stimulation leads for being used in stimulation target nerve structure in patient body includes flexible backings, the flexible backings by the key dimension that extends in the direction of first axle and substantially with first axle same level in and be orthogonal to the minor dimension of first axle and limit.Electrode structure further includes the multiple electrodes for being connected to backing.
Description
Cross reference to related applications
This application claims the priority for enjoying the U.S. Provisional Application 61/846,045 that on July 14th, 2013 submits, the U.S.s
State's provisional application is incorporated herein by reference with it.
Technical field
This disclosure relates to the system and method for stimulating nerve.More specifically, this disclosure relates to for stimulating arteria carotis
The system of the pressoreceptor of sinus and corresponding method.
Background technology
In recent decades, various medical disorders, psychiatric disorders and neurology barrier are treated and controlled using nerve stimulation
Hinder and significantly increase, especially includes for treating heart disease (for example, hypertension), epilepsy, obesity and respiratory disorder.
Invention content
Disclosed herein is each embodiments of the electrode structure for Neurostimulating lead.
In example 1, the electricity of the implantable stimulation leads for being used in stimulating target nerve structure in patient body
Pole structure includes backing, which prolongs by the key dimension that extends in the direction of first axle and generally normal to first axle
The minor dimension stretched limits.Electrode further includes the multiple electrodes for being connected to backing.
In example 2, according to the electrode structure of example 1, wherein backing is suitable for original position and is connected to the remote of implantable lead
End.
In example 3, according to the electrode structure of any one of example 1 or 2, wherein backing is configured to resist to suture and tear
It splits.
In example 4, according to the electrode structure of any one of example 1-3, wherein at least part packet of back member
Include embedded net.
In example 5, according to the electrode structure of any one of example 1-4, wherein the first surface of back member is extremely
A few part includes being suitable for keeping at least part of one or more grooves of suture.
In example 6, according to the electrode structure of any one of example 1-5, wherein the backing, which has, to be suitable for complying with blood
The curved shape of the curvature of pipe.
In example 7, Neurostimulating lead includes：Guidewire body, with portions of proximal and distal part；First leads
Body extends through guidewire body；With the electrode structure according to any one of example 1-6, which is fixed to conducting wire
The distal part of main body.
In example 8, according to the Neurostimulating lead of example 7, wherein backing is substantially rectangular in shape.
In example 9, according to the Neurostimulating lead of any one of example 7 or 8, wherein wherein backing has substantially
Circular periphery edge.
In example 10, according to the Neurostimulating lead of any one of example 7 or 9, wherein backing is substantially elliptical
's.
In example 11, according to the Neurostimulating lead of any one of example 7-10, wherein backing is curved around central axis
Song, the central axis are roughly parallel to the longitudinal axis limited by the distal part of guidewire body.
In example 12, neural stimulation system includes impulse generator, which includes power supply and according to example
The portions of proximal of the Neurostimulating lead of any one of 7-11, Neurostimulating lead is fixed to impulse generator.
In example 13, according to the neural stimulation system of example 12, backing includes flexible material, which includes
Net.
In example 14, according to the neural stimulation system of example 13, wherein net is disposed in the region close to outer periphery
In.
In example 15, according to the neural stimulation system of example 13, wherein net is by equably arrangement throughout the entire of backing
Part.
In example 16, according to the neural stimulation system of any one of example 13-15, wherein wherein net includes polyester.
In example 17, according to the neural stimulation system of any one of example 12-15, wherein backing includes being suitable for drawing
The groove of seam guide line arrangement or hole.
In example 18, according to the neural stimulation system of example 17, wherein groove or hole are extended across at least the one of backing
Part.
In example 19, according to the neural stimulation system of any one of example 17 or 18, wherein groove or hole extend cross
One or combinations thereof in the portions of proximal, distal part of backing.
In example 20, according to the neural stimulation system of any one of example 12-19, wherein the key dimension of backing
Range is from about 12mm to about 16mm.
Although disclosing multiple embodiments, for a person skilled in the art, other embodiments of the invention
It will become apparent from the following detailed description, the following detailed description shows and describes the illustrative embodiment of the present invention.Therefore, attached
Figure and detailed description will be considered as illustrative and not restrictive in nature.
Description of the drawings
Fig. 1 is the schematic diagram of neural stimulation system in accordance with some embodiments.
Fig. 2A-C are respectively one of the Neurostimulating lead of the neural stimulation system in accordance with some embodiments for Fig. 1
Schematic front view, side view and the rearview divided.
Fig. 3 A-C are the schematic diagrames of each embodiment of the electrode structure for the Neurostimulating lead of Fig. 2A-C.
The front view of the electrode structure of the Neurostimulating lead of Fig. 2A-C of some embodiments according to Fig. 4.
The front view of the electrode structure of Fig. 4 of some embodiments according to Fig. 5, shows the inside of electrode structure.
The front view of the electrode structure of Fig. 4 of some embodiments according to Fig. 6 shows the insertion net in electrode structure.
The front view of the alternate embodiment of the electrode structure of some embodiments according to Fig. 7.
Fig. 8-11 is the schematic illustration of each embodiment of electrode structure in accordance with some embodiments, shows to arrange for suture
Feature.
The top view of the electrode structure of some embodiments according to Figure 12.
The top view of the electrode structure of some embodiments according to Figure 13.
Figure 14 is the image for the electrode structure for being sewn onto blood vessel.
Figure 15 provides the schematic illustration of each sample of experiment.
Although the present invention stands the inspection of various modifications and alternative form, specific embodiment leads in the accompanying drawings
It crosses exemplified and is described in more detail below.It is intended, however, that not being to limit the invention to described specific embodiment.
On the contrary, the present invention is directed to cover all modifications fallen within the scope of the present invention defined by the appended claims, equivalent and
Alternative solution.
Specific implementation mode
Fig. 1 is the schematic diagram of the system 2 in the region for showing the nervous system for stimulating patient.In one embodiment,
System 2 stimulation of carotid sinus pressoreceptor so that the heart disease for treating such as hypertension is particularly effective.
As shown, system 2 includes Neurostimulating lead 18 and implantable impulse generator 22.As further shown,
Neurostimulating lead 18 includes electrode structure 26 and guidewire body 34.In embodiments, and as explained in further detail herein
, Neurostimulating lead 18 and the cooperation of electrode structure 26 are to form stimulating electrode component.In the embodiment shown, nerve thorn
Swash conducting wire 18 and be connected to impulse generator 22, impulse generator 22 includes power supply or battery 28.In addition, electrode structure 26 is arranged
In implantation position in patient body.In one embodiment, implantation position is on carotid sinus or adjacent with carotid sinus
Position, for selectively stimulation of carotid sinus pressoreceptor.
As that will be explained further herein, in embodiments, Neurostimulating lead 18 and electrode structure 26 can be with
It is arranged to the independent component being linked together in situ during implantation process.Alternatively, in embodiments, nerve stimulation is led
Line 18 and electrode structure 26 can be integral members, and Neurostimulating lead 18 accommodates electric conductor, and electric conductor is electrically connected to electrode
Electrode in structure 26.
In embodiments, guidewire body 34 is made of elongated and flexible and by the electrically insulating material of bio-compatible,
And include the proximal end 38 that impulse generator 22 is connected to through connector (not shown).In embodiments, guidewire body 34 is
It is generally flexible to allow patient to move.In some embodiments, guidewire body 34 may include one or more guidance cavities with
Guiding elements (such as seal wire or probe) is received so that guidewire body 34 is hardened so as to implantation of performing the operation.
According to each embodiment, Neurostimulating lead 18 may include multiple conductor (not shown), and the multiple conductor includes
Proximally 38 individual electric wire, coil or the cable for extending in one direction electrode structure 26 in guidewire body 34.It can be with
Make to lead using the insulator of the insulating polymer of such as silicones, polyurethane, ethylene tetrafluoroethylene or another bio-compatible
Body insulate.In one exemplary embodiment, conductor has radial design altogether.In some embodiments, each individual conductor
It independently insulate, is then parallelly intertwined to form single coil.In a further exemplary embodiment, conductor has altogether
Axis, non-radial configuration altogether.In embodiments, individual conductor can be sub-thread or multiply coil-conductor.Other other
In embodiment, one or more of conductor is twisted cable conductor, and each conductor is routed through upper in guidewire body 34
State one in chamber.In short, each embodiment is not restricted to the arrangement of any specific conductor in Neurostimulating lead 18.
In embodiments, electrode structure 26 can have multiple suitable constructions, the multiple to be suitably configured to
Effectively stimulation target nerve, such as carotid sinus baroreceptor.In the embodiment shown in fig. 1, it is being implanted patient
After internal and assembled, electrode structure 26 has general bent shaped, can surround or surround a part or entire plant
Enter position.In the embodiment shown, it is fully wrapped around can be configured around implant site for electrode structure 26, but for
For in embodiment, electrode structure 26 can be configured such that the only a part package of the circumference around implant site.
Fig. 2A-C are respectively schematic front view, side view and the rearview according to the electrode structure 26 of each embodiment.Such as figure
Shown in 2A, electrode structure includes backing 44 and a pair of electrodes 50,51.In some embodiments, electrode structure 26 may include
More than two electrode 50,51.As further shown, in embodiments, electrode structure 26 is from the distal end of guidewire body 34 42
Extend or be integrally connected to the distal end 42 of guidewire body 34 (referring to Fig. 1).
As shown in Fig. 2A-C, backing 44 have first surface 52, opposite second surface 54 and first surface 52 with
The side 56 extended between second surface 54.Electrode structure 26 also has distal part 45 and portions of proximal 46.
In embodiments, electrode 50,51 is arranged on the first surface 52 of backing 44 and/or is arranged in backing 44
In at least part.In embodiments, electrode 50,51 may be positioned such that concordant with the first surface of backing 44 52.Other
In embodiment, electrode 50,51 can be protruded from the first surface 52 of backing 44.In some embodiments, electrode 50,51 can be from
First surface 52 is recessed into backing 44.
Each electrode 50,51, which can have, can be delivered to energy at desired position with histio-irritative any appropriate
Size.In some embodiments, electrode 50,51 can be the disk shape for including disk shaped cap and rod type.For example, electrode 50,51
In the head of each can have range from about 0.5mm to the round diameter of about 3mm.Disc electrode 50,51 it is suitable
Diameter may, for example, be 2mm.In other embodiments, electrode 50,51 can be spiral forming, flexible-belt or column forming
's.In other embodiments, electrode 50,51 can be mounted to (spherical shape) end of the spherical forming of bar.
In embodiments, the backing 44 of electrode structure 26 can be formed by flexible electrically insulating material.It can be used for backing
44 suitable polymer may include such as silicones, polyurethane, polysiloxanes urethane, ethylene tetrafluoroethylene (ETFE), gather
Tetrafluoroethene, expansion PTFE (ePTFE) and expansion ultra-high molecular weight polyethylene (eUHMWPE), polyisobutenyl polyurethane
(PIB PU), it is also contemplated that other materials.
Suitable material for electrode 50,51 includes conductive material, and such as platinum, titanium or platinum base alloy are (for example, platinum-
Iridium).In some embodiments, electrode 50,51 can also include the coating being arranged on conductive material.Suitable coating can wrap
Include such as iridium, yttrium oxide, platinum grey, titanium nitride and platinum black.
In some embodiments, at least part of the exposed surface of electrode 50,51 may include increasing electrode 50,51
The feature of surface area.The example for increasing the feature of surface area includes groove, pit, surface texture or other similar spies
Sign.
Fig. 3 A-C show the schematic front view of each representative configuration of electrode structure 26.As shown in Fig. 2A-C, electrode
Structure 26 can be respectively substantially rectangular, oval or round.In some embodiments, the backing 44 of electrode structure 26 can have
Have by thickness T, width W and overall length the L1 flat rectangular shape limited or oval in shape (referring to Fig. 2A-C).In other implementations
In example, electrode structure 26 can have different forms, for example, the circular shape limited by diameter and thickness is (such as institute in Fig. 3 C
Show).Those skilled in the art is it is contemplated that backing 44 can have the various other forms for being suitable for nerve stimulation implantation.
In embodiments, the material for forming electrode structure 26 can have section thickness uniform or heterogeneous.
Fig. 4 is shown with the exemplary electrode structure 26 by width W and overall length the L1 flat oval shape limited.Electrode knot
The suitably sized of structure 26 can allow doctor's more easily suture, or electrode structure 26 is connected to arteria carotis in other ways
Sinus.In some embodiments, the size of electrode structure 26 may include overall length (L1) range of about 13mm to about 18mm, about 8mm
To the width range of about 10mm, and about 0.01mm is to the thickness range of about 1mm.For example, electrode structure 26 can be with 13mm's
The thickness T of the width W and 0.5mm of length L1,8mm.
The overall length L1 and width W of electrode structure 26 can influence to can be used for placing the effective of suture on electrode structure 26
Region.For example, the electrode structure 26 of the width W of length L1 and 8mm with 13mm will likely be sewn to from electrode structure 26
Outer periphery about 3mm in or shorter distance in.In other examples, the electrode structure of the width of the length with 15mm and 10m
26 will likely be sewn in the about 4mm of the outer periphery of electrode structure 26 or is shorter with a distance from.
Fig. 5 is the schematic diagram of electrode structure 26, shows to be suitable for a pair of electrodes 50,51 being connected to a pair of conductors (not shown)
Backing 44 inside 65.In some embodiments, a pair of conductors can also be connected to guidewire body 42 and (do not shown by inside 65
Go out) distal end.As shown, inside 65 may include：A pair of of hole 58,59；Cavity 62；It is connected with by each hole 58,59
To a pair of channels 60,61 of cavity 62.
As shown in Figures 4 and 5, according to some embodiments, the first surface 52 of backing 44 may include being suitable for and electrode
50, a pair of of hole 58,59 of 51 connections.In some embodiments, the size of hole 58 can be designed as partially or substantially connecing
Nano electrode 50.For example, each hole 58,59 can be with diameter D2 or its be sized so as to receive electrode 50 at least one
Point, for example, the bar part of electrode 50.
Electrode 50,51 can be separated from each other suitable distance so that the sensing function of each electrode 50 is not by adjacent electricity
The influence of pole 51.In some embodiments, first electrode 50 arrives the edge-to-edge spacing L2 between second electrode 51 (referring to figure
4), such as electrode is to electrode spacing, and range can be from about 1mm to about 5mm.For example, in some embodiments, suitable electrode arrives
Electrode spacing L2 can be 3mm.
According to some embodiments, the inside 65 of backing 44 can also include multiple channels 60,61, the multiple channel 60,
61 are adapted to allow for cable (not shown) and/or coil to be disposed in backing 44 and are connected to electrode 50,51.In some implementations
In example, at least part of inside 65, for example, a pair of channels 60,61, can be enclosed in the first and second surfaces of backing 44
52, between 54 and side 56 (Fig. 2 B).In other embodiments, at least part of inside 65 be connected to one of backing 44 or
Multiple outer surfaces, for example, cavity 62 may be coupled to the side 56 of backing 44 and form the opening at the side 56 of backing 44.
Channel 60,61 can be separated from each other suitable distance so that the cable in the first and second channels 60,61 is mutually not
It interferes and electrode 50,51 appropriate can be coupled to.In some embodiments, first passage 60 can be with second channel 61
Separate at least distance of 0.25mm.For example, in some embodiments, first passage 60 can separate range with second channel 61 and exist
About 0.5mm and about the distance between 1mm.
In embodiments, the inside 65 of backing 44 can also include cavity 62, and cavity 62 is suitable for receiving conductor and/or leads
The distal end of line main body 42.Cavity 62 can be the region of general tube shape shape, be suitable for receiving conductor and/or cover the pipe of lead conductor
At least part in road (such as, two-chamber sheath).As shown in Figure 5, cavity 62 allows a part for the covering cable of pipeline
It is arranged in backing 44.
In some embodiments, adhesive can distribute in cavity 62 so that cable and sheath are attached to electrode structure 26
Backing 44.In addition, cable and/or coil can be soldered to, adhesively combine or joined by welding technique well known to another kind
Tie electrode 50,51.
As shown in Figure 6, in some embodiments, at least part of backing 44 may include flexible material, the flexibility
Material includes embedded net 64.For example, backing 44 may include silicone material, silicone material includes embedded net 64.At some
In embodiment, net 64 can be disposed in a part for backing 44, such as close to the region of outer periphery, as shown in Figure 6.
In other embodiments, net 64 can be arranged the entire part for equably spreading backing 44.In some embodiments, it is used for embedding
The suitable material of networking 64 may include polyester or other common materials in implantable product.Net can be minimized or auxiliary
Help prevents tearing backing when backing to be sewn onto to the anatomical structure of such as blood vessel.
In embodiments, embedded net 64 includes fibrous structure, which adapts to suture, while minimizing backing 44
Potential tearing.In some embodiments, net 64 may include multiple fibers being randomly aligned.In other embodiments, net
64 may include the fiber with repeat patterns or construction orientation.In some embodiments, embedded net 64 may include close weave
Fiber.In other embodiments, net 64 may include the fiber separated so that given fiber adjoins with one or more
Fiber separates suitable length.
In some embodiments, the outer periphery of backing 44 may be adapted to minimize the arbitrary form in backing 44 in structure
Tearing propagation.As shown in fig. 7, the alternate embodiment of electrode structure 27 can be by forming with backing 44, the backing 44 tool
There is raised outer edge 66, is also been described as spine or lip configuration.In some embodiments, outer edge 66 can be along outer periphery
Increase the thickness of backing 44 to minimize the tearing during suture.
Fig. 8-11 show be suitable for device be implanted into during guide suture arrangement backing 44 groove or through hole 68 it is each
Embodiment.In some embodiments, the backing 44 of electrode structure 26 may include one or more grooves 68, one or more
A groove 68 is also been described as the impression extended along at least part of first surface 52 or recess.According to some embodiments,
One or more grooves 68 are adapted to allow for Suture portions or are disposed entirely in each groove 68.
Alternatively, in some embodiments, backing 44 may include the through hole for being suitable for receiving suture in backing 44
68.For example, one or more through holes 68 can be extended across at least part of backing 44 to opposite the from the first side 56
In two sides 56 and region between first surface 52 and second surface 54.
As illustrated in figs. 8-10, in some embodiments, one or more grooves or through hole 68 can be extended across the back of the body
At least part adjacent with inner cavity of lining 44, for example, channel 60,61 and cavity 62.According to some embodiments, groove or perforation
Hole 68 can be extended across the part of backing, as shown in Figure 2 A, for example, the portions of proximal 46 of backing 44, distal part 45 or
Two parts.Alternatively, in certain embodiments, as shown in figure 11, groove or through hole 68 can be extended across backing 44
The part Chong Die with inner cavity.Such groove or through hole 68 are suitable for extending in the plane of surface of internal cavity, for example, different
Extend in plane so that groove or through hole 68 are not connect with the inner cavity of backing 44.Sufficient suture arrangement can allow will be electric
(Fig. 2A, Fig. 3 A-C, Fig. 4, Fig. 6 and Fig. 7) is positioned to closer vascular wall or anatomical object for pole 50,51, for example, carotid sinus pressure
Ergoreceptor.
Figure 12 and Figure 13 is the top view of electrode structure 26 in accordance with some embodiments, is respectively illustrated with linear structure
With the electrode structure of curved configuration.As shown in these figures, the backing 44 of electrode structure 26 may be adapted to include crooked outline, should
The crooked outline of crooked outline and vascular wall is complementary.For example, backing 44 can be formed as C-shape, as shown in Figure 13.At some
In embodiment, the bending diameter range of backing 44 can be from about 5mm to 15mm.For example, having when electrode structure 26 to be connected to
When the internal carotid of the diameter of approximate 10mm, the range of the bending diameter of electrode structure 26 can be from about 8mm to about 12mm.
Electrode structure 26 can serve as coupling arrangement, which is used for two or more (figures of electrode 50,51
2A, Fig. 3 A-C, Fig. 4, Fig. 6 and Fig. 7) it is positioned proximate to blood vessel (for example, carotid sinus).There are two or more including being connected to
The carotid sinus stimulation system of the Neurostimulating lead 18 of the electrode structure 26 of a electrode 50,51 can be provided to being to be simulated
The improved identification in region.Electrode structure 26 at least two electrodes 50,51 can allow more than one carrier for piercing
Swash.Electrode structure 26 at least two or more electrodes 50,51 can also be by increasing unwanted stimulated in vitro
Threshold value come allow bigger energy convey.
Example 1
The present invention is more specifically described in the following example, following example is expected only as explanation, because of the model of the present invention
Several modifications and variations in enclosing will be apparent for a person skilled in the art.
The sample of electrode structure is assessed based on the preclinical study for the carotid sinus blood vessel for using manikin and corpse
Prototype is with the suitable length L1 of determination.
The sample prototype of the electrode structure of four test groups is by different entire length L1 constructions.Each test group has three
A sample size.The prototype of the research is constructed using 3D printer and is made of standard 3D printing material.
Four test groups, including group A1 to A4 are constructed by different principal length L1.Shown in the table 1 of following article, often
The overall length of the sample of a test group by change the first and second electrodes between edge-to-edge distance L2 and along longitudinal direction
Edge-to-edge distance L3 between 1 each electrode of axis X and the outer periphery of main body is adjusted (referring to Fig. 4).All samples
Size has the constant electrode diameter D1 of 2mm.
Table 1
Sample length data
| Group | Overall length L1 (mm) | L2(mm) | L3(mm) |
| A1 | 12 | 2 | 3 |
| A2 | 16 | 2 | 5 |
| A3 | 13 | 3 | 3 |
| A4 | 17 | 3 | 5 |
Each sample is sewn onto the carotid sinus of human corpse (referring to Figure 14) by animal doctor and is subjectively commented by engineer
Estimate.Group A1 and A3 is assessed as with the suitable length L1 that may be suitable for suturing carotid sinus into the human body.On the contrary, group
A2 and group A4 is assessed as to have too big length L1 and may be not suitable for carotid sinus.The result of the research is built
View, the suitable length range for electrode structure is from about 12mm to 13mm.
Example 2
The present invention is more specifically described in the following example, following example is expected only as explanation, because of the model of the present invention
Several modifications and variations in enclosing will be apparent for a person skilled in the art.
The sample of electrode structure is assessed based on the preclinical study for the carotid sinus blood vessel for using manikin and corpse
Prototype is suitably sized with determination.
The sample of three test groups including group B1 to B3 is constructed using silicone material.Three kinds of sample sizes are for every
A test group.
As shown in table 2 and Figure 15, experiment group B 1-B3 is constructed by different principal length L1 and width W.Each test group
The overall length of middle sample by change the first and second electrodes between edge-to-edge distance L2 and along longitudinal axis X1 it is every
A electrode and edge-to-edge distance L3 between the outer periphery of main body are adjusted (referring to Fig. 4).The sample of all test groups
Constant electrode diameter D1 with 2mm.
Table 2
Sample size data
| Group | Overall length L1 (mm) | L2(mm) | L3(mm) | Width W3 (mm) |
| B1 | 12 | 2 | 3 | 8 |
| B2 | 16 | 2 | 5 | 8 |
| B3 | 16 | 3 | 3 | 12 |
Each sample is sewn onto the carotid sinus of corpse by surgeon and is subjectively commented by surgeon and engineer
Estimate.Group B1 is assessed as may be suitable for being sewn onto the blood vessel of the carotid sinus of the mankind.However, group B2 and B3 is assessed as possibility
It is too big and therefore may be not suitable for carotid sinus suture.Based on these as a result, the width of length and about 8mm with about 12mm
The electrode structure main body of degree will likely be for mankind's carotid sinus electrode structure main body it is suitably sized.
Without departing from the scope of the invention, the exemplary embodiment discussed can be made various modifications and
Addition.For example, although above-described embodiment indicates that specific feature, the scope of the present invention further include having not retouching including all
State the embodiment of the feature of feature and the various combination of embodiment.Therefore, the scope of the present invention is expected to include such as to fall into right to want
It asks together with all such alternative solution, the modifications and variations in the range of its all equivalent.
Claims (17)
1. a kind of electrode structure of implantable stimulation leads for being used in stimulating target nerve structure in patient body, institute
Stating electrode structure includes：
Backing, by the key dimension extended in the direction of first axle and time extended generally normal to the first axle
Want dimension limitation, the backing that there is first surface, the second surface opposite with the first surface and in the first surface
The side extended between the second surface；With
Multiple electrodes are connected to the backing and are arranged in the first surface,
It is extended across at least one through hole of the backing, at least one through hole extends to opposite from first side
Second side, and extend in the region between the first surface and the second surface.
2. electrode structure according to claim 1, wherein the backing is suitable for original position and is connected to the remote of implantable lead
End.
3. electrode structure according to claim 1 or 2, wherein the backing is configured to resist suture tears.
4. electrode structure according to claim 1, wherein at least part of the back member includes embedded net.
5. electrode structure according to claim 1, wherein the backing has the Curved for the curvature for being suitable for complying with blood vessel
Shape.
6. a kind of Neurostimulating lead, including：
Guidewire body, with portions of proximal and distal part；
First conductor extends through the guidewire body；With
According to the electrode structure described in any one of claim 1-5, the electrode structure is fixed to the guidewire body
Distal part.
7. Neurostimulating lead according to claim 6, wherein the backing is substantially rectangular in shape.
8. Neurostimulating lead according to claim 6, wherein the backing has generally circular periphery edge.
9. Neurostimulating lead according to claim 6, wherein the backing is substantially elliptical.
10. Neurostimulating lead according to claim 6, wherein the backing is bent around central axis, the central shaft
Line is roughly parallel to the longitudinal axis limited by the distal part of the guidewire body.
11. a kind of neural stimulation system, including：
Impulse generator comprising power supply；With
According to the Neurostimulating lead described in any one of claim 6-10,
The portions of proximal of the Neurostimulating lead is fixed to the impulse generator.
12. neural stimulation system according to claim 11, wherein the backing includes flexible material, the flexibility material
Material includes net.
13. neural stimulation system according to claim 12, wherein the net is disposed in the region close to outer periphery
In.
14. neural stimulation system according to claim 12, wherein the net is by equably arrangement throughout the backing
Entire part.
15. according to the neural stimulation system described in any one of claim 12-14, wherein the net includes polyester.
16. neural stimulation system according to claim 11, wherein the through hole is extended across the nearside of the backing
Partly, one or combinations thereof in distal part.
17. neural stimulation system according to claim 11, wherein the ranging from 12mm of the key dimension of the backing is extremely
16mm。
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201361846045P | 2013-07-14 | 2013-07-14 | |
| US61/846,045 | 2013-07-14 | ||
| PCT/US2014/046008 WO2015009509A1 (en) | 2013-07-14 | 2014-07-09 | Multi-electrode lead with backing for mecho/baroreceptor stimulation |
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| AU (1) | AU2014290582B2 (en) |
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| US9839785B2 (en) | 2013-12-13 | 2017-12-12 | Cardiac Pacemakers, Inc. | Surgical instrument for implanting leads for baroreceptor stimulation therapy |
| US10029091B2 (en) | 2014-02-20 | 2018-07-24 | Cardiac Pacemakers, Inc. | Apparatus for baroreceptor stimulation therapy |
| WO2015195982A2 (en) | 2014-06-19 | 2015-12-23 | Cardiac Pacemakers, Inc. | Baroreceptor mapping system |
| US9572975B2 (en) | 2014-09-02 | 2017-02-21 | Cardiac Pacemakers, Inc. | Paddle leads configured for suture fixation |
| WO2016044353A1 (en) | 2014-09-16 | 2016-03-24 | Cardiac Pacemakers, Inc. | Paddle leads having asymmetric electrode configurations |
| JP2019524412A (en) * | 2016-08-17 | 2019-09-05 | プイ リン タム， | Non-invasive device for stimulating vulva tissue and pelvic floor muscles to treat and ameliorate dysfunctions or disorders, and probe units used therefor |
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| US9795778B2 (en) | 2017-10-24 |
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| AU2014290582B2 (en) | 2017-08-31 |
| US20150018918A1 (en) | 2015-01-15 |
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| CN105377361A (en) | 2016-03-02 |
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